Weak; Pelvic FloorNCT02549729
Effect of the Pelvic Floor Training in Postmenopausal Women With or Without Hormonal Therapy
A study testing pelvic floor muscle training in people with Weak; Pelvic Floor and Weak; Muscle, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the effect of pelvic floor muscle training (PFMT) on muscle function of postmenopausal women using or not using hormonal therapy replacement (HTR). The study will evaluate also the prevalence of urinary incontinence reports, its severity and impact on quality of life. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Weak; Pelvic Floor, Weak; Muscle, Urinary Incontinence
- What is being tested?
- pelvic floor muscle training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2015to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Postmenopausal women with a maximum of ten years of menopause.
- It is considered menopausal cessation of menstrual cycles for more than twelve months (WHO).
- To be included women must have the ability to contract the pelvic floor muscle (PFM) and have never done PFM training.
Who cannot join
- Women with diabetes mellitus, thyroid disease, hyperprolactinemia, genital prolapse (above grade 1), neuropathy and vasculopathy.
- Those who are intolerant (pain, allergy gel or latex condom or other discomfort) to PFM function evaluation and those that deny answer the questionnaires during the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Pelvic Floor Training on Pelvic Floor Muscle Strength in Postmenopausal Women With or Without Hormonal Therapy: A Randomized Controlled Trial
The purpose of this study is to evaluate the effect of pelvic floor muscle training (PFMT) on muscle function of postmenopausal women using or not using hormonal therapy replacement (HTR). The study will evaluate also the prevalence of urinary incontinence reports, its severity and impact on quality of life.
Read the detailed description
The climacteric period is marked by the decline of estrogens and androgens which represents negative effect on the urogenital system and may present, as a consequence, pelvic floor muscles (PFM) dysfunction and urinary incontinence (UI). The pelvic floor muscles training (PFMT) and hormone therapy (HT) could result in a significant increase in muscle mass with functional improvement and consequent decrease in complaints of urine loss. The aim of this study is to evaluate the effect of PFMT on muscle function, in the presence of UI, severity and impact on quality of life in postmenopausal women with or without HT.
The variable sexual function was abandoned due to the fact that the majority of the women do not presented active sexual life, which is a criteria to answer the questionnaire Index of Female Sexual Function (IFSF), or did not agree to answer the questionnaire. The anxiety scale was also abandoned because it was a tool to assess sexual function in a broader way.
This is a randomized controlled trial. Postmenopausal women will be divided into 4 groups:
- Group 1- without exercise and without HT
- Group 2 - with exercise and without HT
- Group 3 - without exercise and with HT
- Group 4 - with exercise and HT
Women will be evaluated at baseline and up to 12 weeks. The evaluations of the PFM function will be accomplished through the use of vaginal palpation using the Modified Oxford Scale (MOS) and perineometry. The International Consultation on Incontinence Questionnaire- Short Form (ICIQ - SF) will be used to assess reports of UI, quality of life will be evaluated by the SF36 (Medical Outcomes Study 36 - Item Short - Form Health Survey).
The electromyography was not performed because during the collection of data from the pilot sample there was an excess of outcome measures which made the patients' adhesion unfeasible.
- Conditions
- Weak; Pelvic Floor, Weak; Muscle, Urinary Incontinence
- Being tested
- pelvic floor muscle training
- Medical subject headings
- Asthenia, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pelvic floor muscle trainingBehavioural
Women will be instructed to perform pelvic floor muscle training daily at home 4 sets of 10 maximum perceived voluntary contraction of the pelvic floor muscle sustained for 6 seconds followed by 5 flick voluntary contraction of the pelvic floor muscle. The 4 sets will be performed in 4 different positions (supine, all four, sit and standing). Twice a week they will receive a supervised session using the same protocol described above.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control group not using hormonal replacement therapy will not receive supervised pelvic floor muscle training. This group will be assessed at baseline and up to 12 weeks. For ethics reason at the end of the study women of the control group will be invited to receive the pelvic floor muscle training program. However, this will not be part of the study. |
| Exercise | Experimental | Experimental group not using hormonal replacement therapy will receive supervised pelvic floor muscle training. Receives: Behavioral: pelvic floor muscle training |
| Hormone Therapy | No intervention | Experimental group using hormonal replacement therapy will not receive supervised pelvic floor muscle training. |
| Exercise and Hormone Therapy | Experimental | Experimental group using hormonal replacement therapy will receive supervised pelvic floor muscle training. Receives: Behavioral: pelvic floor muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pelvic floor muscle function, evaluated by Perineometry, up to 12 weeks.
Measured: Baseline measurement of pelvic floor muscle function, and up to 12 weeks. Control group will be evaluated at baseline and up to 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weak; Pelvic FloorStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Flávia Ignácio Antônio Vassimon, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02549729
- Sponsor's protocol ID
- 1.076.422
- Status last verified
- Mar 2017
- First submitted
- 1 Sep 2015
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ignacio Antonio F, Herbert RD, Bo K, Rosa-E-Silva ACJS, Lara LAS, Franco MM, Ferreira CHJ. Pelvic floor muscle training increases pelvic floor muscle strength more in post-menopausal women who are not using hormone therapy than in women who are using hormone therapy: a randomised trial. J Physiother. 2018 Jul;64(3):166-171. doi: 10.1016/j.jphys.2018.05.002. Epub 2018 Jun 15.
PubMed 29914808
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Pelvic Floor Training on Pelvic Floor Muscle Strength in Postmenopausal Women With or Without Hormonal Therapy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02549729
- Acronym / sponsor ID
- 1.076.422
- Conditions
- Weak; Pelvic Floor, Weak; Muscle, Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 15 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of pelvic floor muscle training (PFMT) on muscle function of postmenopausal women using or not using hormonal therapy replacement (HTR). The study will evaluate also the prevalence of urinary incontinence reports, its severity and impact on quality of life.
Detailed description
The climacteric period is marked by the decline of estrogens and androgens which represents negative effect on the urogenital system and may present, as a consequence, pelvic floor muscles (PFM) dysfunction and urinary incontinence (UI). The pelvic floor muscles training (PFMT) and hormone therapy (HT) could result in a significant increase in muscle mass with functional improvement and consequent decrease in complaints of urine loss. The aim of this study is to evaluate the effect of PFMT on muscle function, in the presence of UI, severity and impact on quality of life in postmenopausal women with or without HT.
The variable sexual function was abandoned due to the fact that the majority of the women do not presented active sexual life, which is a criteria to answer the questionnaire Index of Female Sexual Function (IFSF), or did not agree to answer the questionnaire. The anxiety scale was also abandoned because it was a tool to assess sexual function in a broader way.
This is a randomized controlled trial. Postmenopausal women will be divided into 4 groups:
- Group 1- without exercise and without HT
- Group 2 - with exercise and without HT
- Group 3 - without exercise and with HT
- Group 4 - with exercise and HT
Women will be evaluated at baseline and up to 12 weeks. The evaluations of the PFM function will be accomplished through the use of vaginal palpation using the Modified Oxford Scale (MOS) and perineometry. The International Consultation on Incontinence Questionnaire- Short Form (ICIQ - SF) will be used to assess reports of UI, quality of life will be evaluated by the SF36 (Medical Outcomes Study 36 - Item Short - Form Health Survey).
The electromyography was not performed because during the collection of data from the pilot sample there was an excess of outcome measures which made the patients' adhesion unfeasible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control group not using hormonal replacement therapy will not receive supervised pelvic floor muscle training. This group will be assessed at baseline and up to 12 weeks. For ethics reason at the end of the study women of the control group will be invited to receive the pelvic floor muscle training program. However, this will not be part of the study. |
| Exercise | Experimental | Behavioral: pelvic floor muscle trainingExperimental group not using hormonal replacement therapy will receive supervised pelvic floor muscle training. |
| Hormone Therapy | No intervention | –Experimental group using hormonal replacement therapy will not receive supervised pelvic floor muscle training. |
| Exercise and Hormone Therapy | Experimental | Behavioral: pelvic floor muscle trainingExperimental group using hormonal replacement therapy will receive supervised pelvic floor muscle training. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Postmenopausal women with a maximum of ten years of menopause.
- It is considered menopausal cessation of menstrual cycles for more than twelve months (WHO).
- To be included women must have the ability to contract the pelvic floor muscle (PFM) and have never done PFM training.
Key exclusion criteria (2 listed)
- Women with diabetes mellitus, thyroid disease, hyperprolactinemia, genital prolapse (above grade 1), neuropathy and vasculopathy.
- Those who are intolerant (pain, allergy gel or latex condom or other discomfort) to PFM function evaluation and those that deny answer the questionnaires during the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pelvic floor muscle trainingWomen will be instructed to perform pelvic floor muscle training daily at home 4 sets of 10 maximum perceived voluntary contraction of the pelvic floor muscle sustained for 6 seconds followed by 5 flick voluntary contraction of the pelvic floor muscle. The 4 sets will be performed in 4 different positions (supine, all four, sit and standing). Twice a week they will receive a supervised session using the same protocol described above. | Behavioural | Exercise, Exercise and Hormone Therapy |
Primary outcome
Change in Pelvic floor muscle function, evaluated by Perineometry, up to 12 weeks.
Time frame: Baseline measurement of pelvic floor muscle function, and up to 12 weeks. Control group will be evaluated at baseline and up to 12 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
- Derived from this study: PubMed 29914808Ignacio Antonio F, Herbert RD, Bo K, Rosa-E-Silva ACJS, Lara LAS, Franco MM, Ferreira CHJ. Pelvic floor muscle training increases pelvic floor muscle strength more in post-menopausal women who are not using hormone therapy than in women who are using hormone therapy: a randomised trial. J Physiother. 2018 Jul;64(3):166-171. doi: 10.1016/j.jphys.2018.05.002. Epub 2018 Jun 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pelvic floor muscle training in people with Weak; Pelvic Floor and Weak; Muscle, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pelvic floor muscle function, evaluated by Perineometry, up to 12 weeks. (time frame: Baseline measurement of pelvic floor muscle function, and up to 12 weeks. Control group will be evaluated at baseline and up to 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02549729, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2017.